Condition: Diabetes Mellitus · Coronary Arterial Disease (CAD) · de Novo Coronary Lesions · Sponsor: Royal College of Surgeons, Ireland
Purpose of this study: The purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own. This study is specifically looking at patients with diabetes who have coronary artery disease. This means that their arteries become restricted or blocked, and these restrictions or blockages are called lesions. The study will look at diabetic patients undergoing treatment for lesions in segments of their coronary arteries that have not previously been treated with stents. These are called 'de novo' lesions. The treatment being investigated: In this study, we are comparing two devices, either used together or on their own to treat coronary artery disease. These devices are commercially available in Europe and carry the mark. This study is being carried out to compare the effectiveness of combining the two devices or using them individually: * Pantera® Lux® Paclitaxel Drug Coated Balloon, abbreviated Pantera® Lux® (DCB) A drug coated balloon is a balloon which is covered by an anti-proliferative drug. * Orsiro® biodegradable polymer Sirolimus Eluting Stent Orsiro® (DES) A stent is a short, wire mesh tube that acts like a scaffold to keep your artery open. A drug eluting stent is coated with medication that reduces the risk of the artery becoming blocked again. Both drug-eluting stents and drug-coated balloons are used routinely for the treatment of 'de novo' coron…
This description comes directly from the study's public registry record.
Amy Carswell, MSc. · +353 (0) 85 880 2094 · amy.carswell@materprivate.ie
Carmen Farrelly, BSc. · carmen.farrelly@materprivate.ie
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| Mater Private Hospital | Dublin, County Dublin, Ireland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07303439